Former CEO and President of Zafgen brings pharmaceutical development and public biotechnology company leadership experience as Navitor builds product pipeline

George P. Vlasuk, Ph.D. to remain as President and appointed Chief Scientific Officer

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Navitor Pharmaceuticals, a biopharmaceutical company targeting the mTORC1 pathway to develop novel therapeutics that help patients live longer and healthier lives, today announced the appointment of Thomas E. Hughes, Ph.D., as Chief Executive Officer. Dr. Hughes is the former Chief Executive Officer of Zafgen (Nasdaq:ZFGN) , a publicly-traded biotechnology company developing medicines for metabolic diseases and has been a scientific advisor to Navitor since its seed stage. George P. Vlasuk, Ph.D., current President and CEO of Navitor, will remain President and will assume the newly-created role of Chief Scientific Officer. Both Dr. Hughes and Dr. Vlasuk will serve on Navitor’s Board of Directors.

These moves come at an exciting time for Navitor, which recently initiated a Phase 1 clinical study of its lead candidate, NV-5138, for treatment-resistant depression (TRD) and is advancing its mTORC1 platform to address multiple therapeutic applications, including CNS, immuno-metabolism, fibrosis and multiple rare diseases.

“We are delighted to bolster the leadership team at Navitor to further strengthen our ability to advance a multi-product pipeline based on our proprietary mTORC1 platform. Tom brings extensive pharmaceutical development and public biotechnology company experience to lead this next stage of Navitor’s growth,” said Alan Crane, Co-founder and Chairman of the Board of Navitor and Entrepreneur Partner at Polaris Partners.

“George has been instrumental in building Navitor to establish the industry-leading capabilities of our mTORC1 platform. George had the foresight to propose bringing a CEO on board with public company and translational experience, while he looks to focus his efforts on continuing to advance the science of Navitor. We are thrilled to have both George and Tom as members of the Navitor leadership team and are confident that with their combined experience, we will be able to advance the company to its next stage of evolution,” continued Mr. Crane.

“I am excited to join Navitor and am eager to work with George and the team he has built to move Navitor through its next stages of growth,” said Dr. Hughes. “mTORC1 is a powerful biological node with proven and tractable approaches to drug development. With a strong platform of proprietary approaches to drugging the mTORC1 system both for selective inhibitors and activators, Navitor is well positioned to lead this field of biology with valuable new insights and therapeutic programs addressing diseases with high and unmet medical need. The recent clinical trial initiation of NV-5138 is the first application of Navitor’s mTORC1 technology in its platform of programs that aim to bring new therapies to patients with limited treatment options.”

Navitor’s small molecule therapeutics are designed to selectively modulate the cellular signals that are aberrant in disease processes caused by the dysregulation of mTORC1 activation. Navitor was founded based on the groundbreaking discoveries related to the mTORC1 pathway and nutrient signaling mechanisms by Dr. David Sabatini at The Whitehead Institute for Biomedical Research.

Dr. Vlasuk commented, “I am excited to focus my efforts on further building the capabilities of Navitor’s mTORC1 platform, expanding our pipeline and shaping the long-term direction of our drug discovery and development efforts. I look forward to working with Tom, whom I have known professionally for many years, to realize our Company’s vision.”

Dr. Tom Hughes, who has more than 30 years of industry experience in the development and commercialization of pharmaceutical products, most recently served as President and Chief Scientific Officer of Zafgen and previously led Zafgen as CEO from 2008 to 2017. During this time, Dr. Hughes established Zafgen as a leading biotechnology company working in the area of rare and prevalent metabolic disorders and led the company through its Initial Public Offering in 2014. Prior to Zafgen, Dr. Hughes held several positions at Novartis including Global Head of the Cardiovascular and Metabolic Diseases Therapeutic Area at the Novartis Institutes for BioMedical Research in Cambridge, MA. In these roles, he oversaw many drug discovery and development projects targeting major global aging-related health issues including obesity, diabetes, and heart disease. Dr. Hughes currently serves as a member of the Board of Directors of miRagen Therapeutics, Inc., is an advisor to Atlas Venture, and is a member of several scientific and strategic advisory boards, including Broadview Ventures, HotSpot Therapeutics, and Nimbus Therapeutics. He holds a Ph.D. in nutritional biochemistry from Tufts University, an M.S. in zoology from Virginia Polytechnic Institute & State University and a B.A. in biology from Franklin and Marshall College.

About NV-5138
NV-5138 is an orally bioavailable, small molecule that is designed to directly and transiently activate mTORC1 activity by binding to and modulating a newly discovered cellular sensor protein for the amino acid leucine, which is a potent natural activator of mTORC1. Unlike leucine, oral administration of NV-5138 results in significant mTORC1 pathway activation in the brain since it is not broken down or incorporated into new proteins. These properties make NV-5138 a unique agent with which to evaluate the role of mTORC1 in brain disorders, such as depression, where mTORC1 activity is often suppressed. Results from preclinical models demonstrate that NV-5138 produces rapid upregulation of key synaptic proteins, synaptogenesis and sustained antidepressant behavioral responses via the transient and direct activation of the mTORC1 signaling pathway. Since NV-5138 does not directly modulate the NMDA receptor pathway, it may not have the side effects and abuse potential observed with several NMDA receptor therapeutics currently in development. NV-5138 is currently being clinically studied for the treatment of major depressive disorder (MDD) with an initial focus on treatment-resistant depression (TRD).

About Navitor
Navitor Pharmaceuticals, Inc. is realizing the potential of modulating mTORC1, the master regulator of cellular function, to develop a pipeline of therapeutics that help patients live longer and healthier lives. Our industry leading team is unlocking the promise of recent discoveries in mTORC1 biology to address a broad range of chronic diseases. Our initial clinical application is a first-in-class drug to address unmet needs in depression. For more information, please visit www.navitorpharma.com.